Table 4

 Safety summary

Dose reduction (n=121)Usual care (n=59)Difference (95%CI)
Flares
All flares88 (73)16 (27)46% (30% to 58%)
Major flares15 (12)6 (10)2% (−9% to 11%)
Other adverse events
Adverse events95 (79)45 (76)2% (−9% to 16%)
Serious adverse events*30 (25)7 (12)13% (−1% to 24%)
Planned surgery11 (9)1 (2)7% (−1% to 14%)
PET/CT scan related†4 (3)
Cardiovascular event5 (4)1 (2)2% (−5% to 8%)
Infectious adverse event3 (2)3 (5)−3% (−12% to 3%)
Malignancy6 (5)2 (3)2% (−7% to 8%)
Allergic (injection) reaction000
Death000

Data are no (%) of patients. Cumulative incidence at 18 months: no of patients with at least one event in the study period. PET/CT=positron emission tomography/computed tomography.

*Four patients (all in the dose reduction group) had two serious adverse events each.

†Patients allocated to the dose reduction group were asked for a substudy, which included a whole body PET/CT scan. Four patients were diagnosed with extra-articular abnormalities that needed explorative surgery.